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Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Andrea di Bello
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

Articoli con TAG: biomarcatori

I biomarcatori di danno renale acuto
Biomarkers of acute kidney injury
<p>The diagnosis and follow-up of acute kidney injury (AKI) has traditionally been based on clinical parameters such as urine output, and/or biomarkers such as serum creatinine (sCr), which are not very sensitive. The identification and validation of novel biomarkers, capable of recognizing an increased risk of AKI, a renal damage before or without a functional renal loss (i.e. subclinical AKI) and a renal dysfunction prior to the increase in sCr levels, has reviewed the diagnosis and classification of AKI. Thanks to these biomarkers, a new conceptual model of AKI, that includes the full spectrum of events and conditions, has been developed. At each stage of this model, biomarkers may contribute to explain the mechanisms and to predict the clinical evolution of kidney damage. Several biomarkers have been identified. They differ in anatomical origin, physiological function, kinetics and detecting time after kidney injury.<br />The present review describes the main biomarkers&rsquo; characteristics and their role in the clinical practice.</p>
Biochimica Clinica ; 17(1)
Rassegne - Reviews
Il ruolo del laboratorio clinico nella diagnosi precoce di preeclampsia
The role of the clinical laboratory in the early diagnosis of preeclampsia
<p>Hypertensive pregnancy disorders include a large spectrum of conditions, including pre-existing chronic hypertension, gestational hypertension, preeclampsia (PE) and eclampsia. In particular, PE is one of the most important causes of maternal morbidity and mortality and perinatal death, preterm birth, and delayed intrauterine growth. The studies support a pathogenetic model of insufficient placentation which results in a vicious circle clinically dominated by an increase in blood pressure and proteinuria in the first phase, and by the involvement of the central nervous system up to convulsions in the more advanced stages. A crucial aspect of patient management is therefore represented by the identification of biological markers measurable in maternal blood (circulating) useful in the diagnosis, prognostic stratification and monitoring. In particular, in recent years many resources have been used to identify a biophysical and biochemical screening test aimed at identifying women at greater risk of PE, but none of these tools when used alone has demonstrated a significant predictive value. Few biomarkers are currently used in clinical practice. The analysis of the literature suggests that angiogenic and anti-angiogenic molecules, in particular the fms-like-tyrosine-kinase receptor 1 and placental growth factor (sFlt-1/PlGF) ratio, can be considered the biomarkers with the best diagnostic performance in the second trimester of pregnancy. However, doubts remain about their use in clinical practice before the 20th gestational week.</p>
Biochimica Clinica ; 45(1) 015-025
Rassegne -
I micro-RNA quali potenziali biomarcatori per la diagnosi e la prognosi del cancro del pancreas: scelte metodologiche e criticità
Micro-RNAs as potential diagnostic and prognostic biomarkers in pancreatic cancer: methodological choices and issues
<p>Pancreatic cancer is the fourth cause of the death by cancer worldwide. It remains the only cancer whose survival has not improved in the last 40 years (only 18% of patients are still alive after 1 year, and 5% after 5 years), because of the high metastatic capacity and chemoresistance of the tumour. Complete tumour resection offers a chance to improve prognosis, but only 20% of patients are suitable for surgery. Although carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA 19-9) are commonly used biomarkers in clinical practice, they are not sufficiently sensitive and specific for early diagnosis neither for predicting response to treatment. The search for biomarkers for early diagnosis, post-operative surveillance and prognosis prediction is therefore fundamental in the context of pancreatic cancer.<br />Circulating micro-RNAs (miRNAs), emerging regulators of gene expression, have been reported by several studies as powerful non-invasive biomarkers in the pancreatic cancer setting, because of their presence and stability in human body fluids. Distinctive miRNAs expression profiles have been associated to pancreatic cancer; furthermore, changes in their expression seems to identify cancer development and response to treatment. Although many papers have been published in this field, the results are still controversial and no consensus has reached about sample type, methodologies and protocols to be adopted thus hampering their introduction into routine practice. This paper aims to summarize the methodological choices in the analysis of circulating miRNAs with particular focus on the critical points of the different phases of the process.</p>
Biochimica Clinica ; 45(1) 026-034
Rassegne - Reviews
Biomarcatori cardiaci: dove stiamo andando?
Cardiac biomarkers: where are we going?
<p>The measurement of cardiac troponins (cTn) is recommended by all guidelines as the gold standard for the detection of differential myocardial injury and acute myocardial infarction (AMI). In this article, some key issues regarding both analytical characteristics of the high-sensitivity methods for cTn, which are still considered controversial or unresolved are discussed in details. These issues have been included in the activities of the Joint Working Group on &ldquo;Cardiac Biomarkers&rdquo; of the Italian Society of Clinical Biochemistry and the Italian branch of the European Ligand Assay Society. The major clinical concern regarding hs-cTn methods is the difficulty to differentiate the pathophysiological mechanism responsible for biomarker release from cardiomyocytes after reversible or irreversible injury, respectively. High-sensitivity cTnI and cTnT methods (hs-cTn) enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk of heart failure. In addition, several studies demonstrated that the cardiovascular risk progressively increases in the general population even for hs-cTn values well below the 99th percentile, i.e. the recognized cut-off for the detection of myocardial injury and diagnosis of AMI. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Finally, recent studies support the working hypothesis that a new generation of hs-cTn methods should be set up based on monoclonal antibodies, specific for circulating peptide forms more characteristics for reversible rather than irreversible myocardial injury. Of course, screening programs of cardiovascular risk stratification and prevention strategies using hs-cTn methods require further investigation to define the optimal target populations, timing of measurement, and preventive interventions.</p>
Biochimica Clinica ; 45(1) 068-074
Documenti - Documents
Validazione di nuovi marcatori di neoplasia: la posizione ufficiale dell’“European Group on Tumor Markers”
Validation of new cancer biomarkers: a position statement from the European Group on Tumor Markers
<p>Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use. In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study. Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit.</p>
Biochimica Clinica ; 41(1) 102-113
Il meglio di Clinical Chemistry - Clinical Chemistry Highlights
Ruolo dei biomarcatori per la diagnosi precoce e il monitoraggio delle malattie neurologiche
Biochimica Clinica ; 44(2) 117-118
Editoriale - Editorial
Accuratezza dell’immunonefelometria come metodo di screening per la determinazione della proteinuria di Bence Jones
Accuracy of immunonephelometry as a screening method for Bence Jones proteinuria
<p>The Bence Jones protein (BJP) is an important biomarker for the identification and management of patients with plasma cell dyscrasia. The recommended method for BJP detection is the immunofixation, which is a time consuming and expensive procedure. The aim of the study was to evaluate immunonephelometry (INA) as a screening method for the identification of urine samples negative for BJP and to compare it to a simplified immunofixation method (uIFE-3). First morning urine samples were collected from 1000 consecutive patients and analyzed by INA. Samples with free light chain concentrations &gt;10 mg/L and &gt;5 mg/L were considered positive. All samples were further analyzed by uIFE-3 using 3 antisera (anti-GAM, -&kappa; and -&lambda;). The INA results (at both cut-off levels) were compared with the uIFE-3, showing a poor accuracy due to the high number of false positives and false negatives. Consequently, INA resulted unable to accurately screen BJP.</p>
Biochimica Clinica ; 41(2) 148-153
Contributi scientifici - Scientific papers
Copeptina e patologie cardiocerebrovascolari
Copeptine in cardiocerebrovascular disease
P. Pezzati, F. Balboni
<p>Copeptin (CP) is a 39 amino acid glycopeptide including the Cterminal&nbsp;domain of the arginine vasopressine precursor. CP is known to be a stable and sensitive surrogate marker&nbsp;for arginine-vasopressine release and it has been investigated as possible diagnostic and prognostic marker in&nbsp;cardiovascular and cerebrovascular diseases. In particular, the role of CP in the early diagnosis of acute myocardial&nbsp;infarction has been widely investigated and various systematic reviews are currently available. CP associated with&nbsp;cardiac troponin T has been reported to carry a good diagnostic accuracy. These data need, however, to be revised&nbsp;according to the introduction of highly sensitive assays for measuring troponins. Although some evidence on the&nbsp;prognostic value of CP in various cardiovascular frameworks is available, natriuretic peptides maintain a leading role.&nbsp;The research on CP is currently investigating its prognostic value in stroke and transient ischemic attack. However,&nbsp;due to the small sample size of studies and the lack of sound evidence, there are no minimal indications for&nbsp;requesting CP in this framework.</p>
Biochimica Clinica ; 39(3) 168-177
Rassegne - Reviews
Confronto tra marcatori sierici di fibrosi e biopsia epatica
A comparison between serum biomarkers of fibrosis and liver biopsy
V. Pecoraro, R.M. Russo, G. Perricone, S. Brenna, S. Granata
<p>Hepatic fibrosis is a common response to&nbsp;prolonged liver injury and the liver biopsy is the standard method for assessing it. However, searching for alternative&nbsp;noninvasive approaches is important and immunoenzymatic assays using monoclonal antibodies have been recently&nbsp;developed to investigate the diagnostic utility of serum biomarkers. In this study, we explore the relationship between&nbsp;the grade of liver fibrosis and some biochemical parameters. We considered the following markers: collagen IV (CIV),&nbsp;coliglicin (CG), hyaluronic acid (HA), laminin (LN) and aminoterminal procollagen type III peptide (PIIIP). All markers&nbsp;were analyzed by new chemiluminescence immunoassays. We enrolled 36 patients with liver disease and available&nbsp;liver biopsy data. Furthermore, we compared the serum marker concentrations of patients with those of 16 healthy&nbsp;volunteers. Results showed a significant increase in concentrations of CIV, CG and PIIIP in patients with liver fibrosis.&nbsp;For CIV and PIIIP, a significant difference was also observed among groups with different fibrosis grade. In particular,&nbsp;a significant increase was evident in patients with early fibrosis when compared to patients without fibrosis.</p>
Biochimica Clinica ; 39(3) 188-192
Contributi scientifici - Scientific Papers
Raccomandazioni italiane di consenso per una diagnosi eziologica basata sui biomarcatori in pazienti con deterioramento cognitivo lieve
Italian consensus recommendations for a biomarker-based aetiological diagnosis in mild cognitive impairment patients
<p>Background and purpose: Biomarkers support the aetiological diagnosis of neurocognitive disorders in vivo. Incomplete evidence is available to drive clinical decisions; available diagnostic algorithms are generic and not very helpful in clinical practice. The aim was to develop a biomarker-based diagnostic algorithm for mild cognitive impairment patients, leveraging on knowledge from recognized national experts.<br />Methods: With a Delphi procedure, experienced clinicians making variable use of biomarkers in clinical practice and representing five Italian scientific societies (neurology &ndash; Societa Italiana di Neurologia per le Demenze; neuroradiology &ndash; Associazione Italiana di Neuroradiologia; biochemistry &ndash; Societa Italiana di Biochimica Clinica; psychogeriatrics &ndash; Associazione Italiana di Psicogeriatria; nuclear medicine &ndash; Associazione Italiana di Medicina Nucleare) defined the theoretical framework, relevant literature, the diagnostic issues to be addressed and the diagnostic algorithm. An N&ndash;1 majority defined consensus achievement.<br />Results: The panellists chose the 2011 National Institute on Aging and Alzheimer&rsquo;s Association diagnostic criteria as the reference theoretical framework and defined the algorithm in seven Delphi rounds. The algorithm includes baseline clinical and cognitive assessment, blood examination, and magnetic resonance imaging with exclusionary and inclusionary roles; dopamine transporter single-photon emission computed tomography (if no/unclear parkinsonism) or metaiodobenzylguanidine cardiac scintigraphy for suspected dementia with Lewy bodies with clear parkinsonism [round VII, votes (yes-no-abstained):3-1-1]; 18F-fluorodeoxyglucose positron emission tomography for suspected frontotemporal lobar degeneration and low diagnostic confidence of Alzheimer&rsquo;s disease (round VII, 4-0-1); cerebrospinal fluid for suspected Alzheimer&rsquo;s disease (round IV, 4-1-0); and amyloid positron emission tomography if cerebrospinal fluid was not possible/accepted (round V, 4-1-0) or inconclusive (round VI, 5-0-0).<br />Conclusions: These consensus recommendations can guide clinicians in the biomarker-based aetiological diagnosis of mild cognitive impairment, whilst guidelines cannot be defined with evidence-to-decision procedures due to incomplete evidence.</p>
Biochimica Clinica ; 44(2) 194-205
Documenti SIBioC - SIBioC Documents
Amiloidosi AL: il cuore del problema
AL amyloidosis: the heart of the problem
M. Vidus Rosin, G. Palladini, G. Merlini
<p>Immunoglobulin light chain amyloidosis (AL) is characterized by the&nbsp;production of immunoglobulin light chains with conformational abnormalities that cause systemic toxicity with rapid&nbsp;deterioration of the function of vital organs. When the heart is involved, as it is the case in ~3/4 of patients, clinical signs&nbsp;and symptoms often appear when organ damage is already irreversible and the treatment cannot longer change the&nbsp;course of disease. Although in recent years new powerful therapeutic regimens have become available, which are able&nbsp;to significantly improve long-term survival, the mortality rate in the first year after diagnosis has indeed not improved, still&nbsp;being 25-30%. Cardiac involvement is responsible for almost all of these deaths. Early diagnosis based on biochemical&nbsp;markers of the disease rather than on clinical symptoms and signs can allow for early detection of patients with cardiac&nbsp;amyloidosis and to establish an effective therapy. To this end, our group has proposed the introduction of the&nbsp;measurement of natriuretic peptides that can identify the presence of amyloid cardiomyopathy with a sensitivity of 100%&nbsp;in the monitoring of subjects with monoclonal gammopathies of undetermined significance (MGUS) and altered ratio of&nbsp;circulating free light chains (FLC). Individuals with MGUS and altered FLC ratio are at intermediate/high risk of&nbsp;developing a malignant disease (AL amyloidosis in 10-15% of cases) and, according to the guidelines of the International&nbsp;Myeloma Working Group, they should be monitored regularly for their entire life. Here we describe a case where the&nbsp;application of these recent recommendations has allowed the timely recognition of amyloid cardiomyopathy.</p>
Biochimica Clinica ; 39(3) 220-222
Casi clinici - Case report
L’uso dei biomarcatori del liquido cerebrospinale nella diagnosi della malattia di Alzheimer: un’indagine tra i laboratori italiani
The clinical use of cerebrospinal fluid biomarkers for Alzheimer’s disease diagnosis: an Italian survey
<p>The use of cerebrospinal fluid (CSF) biomarkers amyloid <span style="font-family:symbol; font-size:12.0pt">b</span><sub>1-42</sub> (A<span style="font-family:symbol; font-size:12.0pt">b</span><sub>42</sub>), tau (T-tau), and phosphorylated tau (p-tau<sub>181</sub>) for the diagnosis of Alzheimer&rsquo;s Disease is limited to a restricted number of neurological centers. By a survey, we aimed to do a &ldquo;selfie&rdquo; of the use and diffusion of CSF biomarkers of dementia in Italy, the standardization of pre-analytical procedures, the harmonization of ranges, and the participation to Quality Control programs. The members of SIBioC and of the Piattaforma Italiana per le Malattie Neurodegenerative della Societ&agrave; Italiana di Neurologia per le Demenze (SINdem-ITALPLANED) together with other neurological clinics all over Italy have received an online questionnaire. Forty neurological centers require CSF analyses while 7/20 regions (35%) lack CSF laboratories. Standardization of pre-analytical procedures is present in 62.02% of laboratories and only 56% participate to International Quality Control Programs. There is no harmonization of the reported cut-offs. A cost-benefit analysis, with a program for standardization and harmonization should be promoted by Scientific Societies and National Health Services.</p>
Biochimica Clinica ; 42(1) 39-43
Contributi scientifici - Scientific papers
Patologie cardiovascolari e troponine cardiache: la storia di un legame indissolubile
Cardiovascular diseases and cardiac troponins: the history of a lasting connection
<p>The evolution of the biochemical diagnosis of cardiac diseases, represents a paradigm of the laboratory medicine evolution in the recent years.<br />Starting from the use of poor specific and sensitive biomarkers, the &ldquo;so-called&rdquo; cardiac enzymes (aspartate aminotransferase; lactate dehydrogenase; creatine kinase) recommended by World Health Organization for the acute myocardial infarction (AMI) diagnosis, a fundamental development in biochemical knowledge has been obtained, providing new biomarkers (CK-MB, myoglobin) for a more specific and early diagnosis according to the clinical and therapeutic needs. However, the revolutionary biochemical issue has been represented by the discovery of cardiac troponins and by the implementation of methods allowing their measurement in emergency setting in patients with acute chest pain. Cardiac troponins, are characterized by an absolute cardiac specificity and by a high sensitivity that allow to carry out a timely and safe diagnosis of AMI, being recognized as &ldquo;gold standard&rdquo; in all clinical and biochemical guidelines. In patients with acute chest pain and in ischemic clinical setting, a typical kinetic release of biomarker concentration may be suggestive of AMI even if ECG typical patterns are lacking. The actual improvement in analytical performance of troponins methods, particularly in the analytical sensitivity, allows to extend the measurement also in diagnosis of minor myocardial damage in patients suffering from different cardiac disease, to monitor the efficacy of therapy, the progression of the disease and to provide prognostic information and risk-stratification in addition to the clinical pathway.</p>
Biochimica Clinica ; 44(2) S067-S073
Opinioni - Opinions